6505-- Supplies - PET MRI Radiopharmaceuticals - Detroit

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items

Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 9

REVISION: 00

Acquisition ID#: 36C250-24-AP-4117

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C250-24-AP-4117

Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10 in support of Department of Veterans Affairs, VISN 10, John D. Dingell VA Medical Center, 4646 John R Street, Detroit, MI 48201

2237: 553-25-1-089-0002

Nature and/or Description of the Action Being Processed: This is a request for other than full and open competition for a sole source procurement to obtain PET MRI radiopharmaceuticals in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This action will be awarded as a new open market, firm-fixed price purchase order with period of performance October 1, 2024 through September 30, 2025. The estimated value of the proposed action is $500,000.00.

Description of Supplies/Services Required to Meet the Agency s Needs: Contractor will furnish (including packaging, transportation, manifests, and reports) all PET radiopharmaceuticals ordered from the Schedule of Supplies to the John D. Dingell VA Medical Center, 4646 John R Street, Detroit, MI 48201 for period of performance October 1, 2024 through September 30, 2025. These are PET radiopharmaceutical supplies used in Nuclear Medicine to perform exams on PET MRI patients. This is not a bundled requirement and there are no organizational conflicts of interest.

Description of radiopharmaceuticals being requested:

Product Name Unit of Measure Est. Annual Quantity

1. Cu64 Dotatate 3-5 mCi Each 10 doses

2. F18 PSMA 8-10 mCi Each 52 doses

3. F18 FDG 8-10 mCi Each 780 doses

4. F18 Vizamyl 8-10 mCi or Each 52 doses

F18 Neuraceq 8-10 mCi or

F18 Amyvid 8-10 mCi

Statutory Authority Permitting Restricted Competition:Â

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement.  Competition is restricted on this procurement for the reason below:

       (X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

       ( ) Unusual and Compelling Urgency

       ( )  Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

       ( ) International Agreement

       ( ) Authorized or Required by Statute

       ( ) National Security

       ( ) Public Interest

Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The specific PET MRI radiopharmaceuticals listed in Section 3 have been determined by Detroit VAMC physicians and nuclear medicine staff to best meet the needs of the veteran population at the Detroit VAMC. Based on the market research, Sofie, Co. is currently the only vendor capable of providing all the required radiopharmaceuticals. Sofie, Co. is a small business manufacturer and distributor. It has received FDA approval for F18 Fluorodeoxyglucose (FDG), manufactures Neuraceq (F18 Florbetaben) under agreement with Piramal Imaging, manufacturers and distributes F18 PSMA (Pylarify) through a partnership with Lantheus (Progenics), and distributes Cu64 Dotatate (Detecnet) through a partnership with Curium.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted, details of which are in the market research

section of this document. This effort did not yield any additional sources that can meet all the

Government s requirements. There is no competition anticipated for this acquisition.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will ensure that the anticipated cost to the Government will be

fair and reasonable. The Contracting Officer will make a fair and reasonable price determination

based on a comparison of proposed pricing to historical prices from Sofie, Co. for the radiopharmaceuticals.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Search of VetCert using NAICS 325412 resulted in 134 potential SDVOSB/VOSB s. Search of SBA DSBS using NAICS 325412 and keywords PET Radiopharmaceuticals resulted in zero vendors. Search of the VA NAC Pharmaceutical Catalog resulted in existing sources for the CU-64 Dotatate (Detectnet) from Curium US and the F18 Florbetapir (Amyvid) from Eli Lilly, but no other existing sources found for all other radiopharmaceuticals. The procurement for Detroit s current PO 36C25022P0537 was originally competed in the open market as unrestricted for eight different radiopharmaceuticals, but no vendor could provide all eight. A new RFQ was issued for F18 Neuraceq, F18 FDG, and F18 PSMA. Quotes were received from Sofie, Co., Cardinal Health, and PETNET Solutions, but only Sofie, Co. provided a quote for all three, and award was made to Sofie, Co. as the only capable vendor. Sources sought notice 36C25024Q0867 was published on Contract Opportunities from July 25,2024 through August 2, 2024. Responses were received from Sofie, Co., Cardinal Health, and PETNET Solutions. Detroit Nuclear Medicine staff reviewed the responses and determined that Cardinal Health and PETNET Solutions could not provide F18 PSMA. Cardinal Health also stated they could not provide F18 Vizamyl, F18 Neuraceq, or F18 Amyvid. Sofie, Co. was the only vendor capable of providing all the required radiopharmaceuticals. In its capability statement, Sofie, Co. indicated it is a small business manufacturer and distributor. It has received FDA approval for F18 Fluorodeoxyglucose (FDG), manufactures Neuraceq (F18 Florbetaben) under agreement with Piramal Imaging, manufacturers and distributes F18 PSMA (Pylarify) through a partnership with Lantheus (Progenics), and distributes Cu64 Dotatate (Detecnet) through a partnership with Curium. The Buy American statute applies to this acquisition. Sofie, Co. s radiopharmaceutical cyclotron is located in Romeoville, IL.

Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other

supporting facts.

Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Sofie, Co. (fka Zevacor Pharma, Inc.)

21000 Atlantic Blvd., Suite 730

Dulles, VA 20166

Cardinal Health 414, LLC

7000 Cardinal Place

Dublin, OH 43017

PETNET Solutions, Inc.

810 Innovation Drive

Knoxville, TN 37932

A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The

proposed contract action is for a period of one year. After the one year, the market will be surveyed to determine if there are other sources that could lead to a competitive procurement. Awarded contract 36C25025P0030 to SOFIE CO. for 493264.44000000 on 2024-10-01.